To Evaluate Safety, and to treat Adolescent Patients with Schizophrenia
- Conditions
- Health Condition 1: null- Adolescent Patients with Schizophrenia
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 150
1. Written informed consent/assent obtained from a legally
acceptable representative (e.g., guardian) prior to the
initiation of any protocol-required procedures. In addition,
the subject must provide informed assent at screening and
must be able to understand that he or she can withdraw
from the study at any time. All informed consent/assent
procedures must be in accordance with the study centerâ??s
institutional review board/ethics committee (IRB/IEC)
and local regulatory requirements.
2. Male and female subjects aged 13 to 17 years, inclusive,
at the time of informed consent/assent until randomization
in Phase 3.
3. Subjects with a current diagnosis of schizophrenia, as
defined by DSM-IV-TR criteria and confirmed by the
K-SADS-PL, and a history of the illness (diagnosis or
symptoms) for at least 6 months prior to screening (as per
subject, family, or healthcare provider, or by previous
medical records). The initial diagnosis of schizophrenia
must be made and documented initially by an adequately
trained clinician (e.g. adolescent psychiatrist or local
medical equivalent), and the diagnosis should be
confirmed afterwards by utilizing the K-SADS-PL
performed by an adequately trained clinician.
4. Subjects who, in the investigatorâ??s judgment, require
treatment with antipsychotic medication(s).
5. Subjects who have shown previous response to
antipsychotic treatment (other than clozapine unless
clozapine is the only available treatment) and are not
resistant to treatment with other antipsychotics, according
to the investigatorâ??s clinical judgment.
6. Subjects who are currently being treated with oral or
depot antipsychotics other than clozapine, unless
clozapine is the only available treatment and subjects are
not resistant to treatment with other antipsychotics.
7. Subjects with a history of relapse and/or exacerbation of
symptoms when they are not receiving antipsychotic
treatment.
8. Inpatient or outpatient status.
9. Ability of the subject and the subjectâ??s legally acceptable
representative (e.g., guardian) or caregiver(s) to
comprehend and satisfactorily comply with the protocol
requirements (including the prescribed dosage regimens,
tablet ingestion, and discontinuation of prohibited
concomitant medications), to read and understand the
written word in order to complete subject-reported
outcomes measures, and to reliably rate assessment scales.
10. Females of childbearing potential must have a negative
pregnancy test, must be practicing acceptable double
barrier methods of contraception (or can confirm
abstinence), and must not be pregnant or lactating.
11. Subjects who are receiving antipsychotic(s) other than
aripiprazole or clozapine (unless clozapine is the only
available antipsychotic agent and the subject is not
resistant to other antipsychotic treatment) must be crosstitrated
to aripiprazole monotherapy over 4 to 6 weeks
using an initial dose of 2 mg/day in Phase 1 to achieve a
recommended aripiprazole monotherapy minimum target
dose of 10 mg/day in order to enter Phase 2, but higher
doses may be achieved based on the subj
Sex and Reproductive Status
1. Sexually active males who are not practicing double-barrier
birth control or who will not remain abstinent during the
study and for 90 days following the last dose of study
medication, or sexually active females of childbearing
potential who are not practicing double-barrier birth control
or who will not remain abstinent during the study and for
30 days following the last dose of study medication.
Abstinence will be permitted if it is confirmed and
documented at every study visit. If employing birth control,
two of the following precautions must be used: vasectomy,
tubal ligation, vaginal diaphragm, intrauterine
device (IUD), birth control pill, birth control depot
injections, birth control implant, condom or sponge with
spermicide.
2. Females who are breast-feeding and/or who have a positive
serum pregnancy test result prior to receiving study drug.
Target Disease
3. Subjects with a current DSM-IV-TR diagnosis other than
schizophrenia, including an Axis I (DSM-IV-TR) current
diagnosis of schizoaffective disorder or current diagnosis of
major depressive disorder, or bipolar disorder with or
without psychotic features. Also, subjects with any of the
following Axis II (DSM-IV-TR) diagnoses: borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial
personality disorder.
4. Subjects with a clinical presentation and/or history that is
consistent with delirium, dementia, amnesia or other
cognitive disorders; subjects with psychotic symptoms that
are better accounted for by another general medical
condition(s) or direct effect of a substance (i.e., medication,
illicit drug use, etc.).
5. Subjects with attention deficit disorder or attention deficit
hyperactivity disorder and/or the patient was on stimulant
treatment for any period of time over the last one year prior
to screening.
6. Subjects with a clinical presentation and/or history of any
neurodevelopmental disorder.
7. Subjects experiencing acute depressive symptoms within
the past 30 days prior to screening that require treatment
with an antidepressant, according to the investigatorâ??s
judgment.
8. Subjects with schizophrenia that is considered treatment
resistant to antipsychotic medication, including relapse
while on adequate doses of aripiprazole, by history.
9. Subjects with a history of failure of clozapine treatment or
response to clozapine treatment only.
Medical History and Concurrent Disease
10. Subjects who have a significant risk of committing suicide
based on history (e.g., suicide attempt in the past 1 year) or
routine psychiatric status examination, or who have an
answer of â??yesâ?? on Questions 4 or 5 (current or over the
last 30 days) on the suicidal ideation section of the baseline
screening version of the C-SSRS.
11 Subjects who have met DSM-IV-TR criteria for substance
dependence (including alcohol and benzodiazepines, but
excluding caffeine and nicotine) within the past 180 days
prior to screening.
12.Subjects who have epilepsy, a history of seizures (except
for a single childhood febrile seizure or post-traumatic
sei
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to evaluate the efficacy of aripiprazole compared <br/ ><br>with placebo, as measured by time to exacerbation of psychotic symptoms/impending <br/ ><br>relapse, in adolescent schizophrenic subjects who have maintained stability for <br/ ><br>2 consecutive weekly time points on oral aripiprazole with at least 7 weeks of treatment.Timepoint: 2.5 yrs
- Secondary Outcome Measures
Name Time Method 2.5 yrs <br/ ><br>Timepoint: The following secondary efficacy endpoints will be compared <br/ ><br>in Phase 3 between the aripiprazole treatment group and the <br/ ><br>placebo group at endpoint: <br/ ><br>â?¢ Percentage of subjects meeting exacerbation of psychotic <br/ ><br>symptoms/impending relapse criteria <br/ ><br>â?¢ Percentage of responders in each treatment group (ie, <br/ ><br>response defined as meeting stability criteria) <br/ ><br>